Implanet Snags CE Mark and FDA Approval for Jazz Implant Diameters
Implanet has won dual FDA and CE Mark approval of its Jazz band implant for adolescent scoliosis and deformity and degenerative spinal disorder treatment in adults, in its 3.5-, 4.0-, 4.5-, and 6-mm sizes, the French devicemaker announced Tuesday. The product’s original 5.5-mm version was previously cleared by the agencies.
The device’s single-screw design enables optimal band tensioning, allowing for robust fixation. The implant features no metal in the canal, which means no follow-up imaging is necessary, and comes with a single tensioning instrument for reduction, translation and derotation, the company says.
More than 6,000 Jazz devices have been implanted since the product was launched in 2013.
Implanet was founded in 2007 as an orthopedic implant manufacturer. It recorded sales of about $7.8 million in 2014. — Jason Scott